Novofem tablets

Novofem® is a sequential combined hormone replacement therapy (HRT) which is taken every day without interruption. Novofem® is used in postmenopausal women with at least six months since their last natural period.

Novofem® contains two hormones, an oestrogen (estradiol) and a progestagen (norethisterone acetate). The estradiol in Novofem® is identical to the estradiol produced in the ovaries of women, and is classified as a natural oestrogen. Norethisterone acetate is a synthetic progestagen, which acts in a similar manner as progesterone, another important female sex hormone.

Novofem® is used to treat the symptoms of menopause. Typical symptoms include:

• Hot flashes.
• Nocturnal hot flashes (night sweats).
• Sleep problems.
• Dryness of mucous membranes (which may lead to complications such as vaginal discomfort).

This medicine is also prescribed to reduce the risk of osteoporosis after menopause. Osteoporosis is a disease in which bones become weak and brittle, causing them to fracture more easily. See the package leaflet for more information on this topic.

Take one tablet once a day, at about the same time each day. Each pack contains 28 tablets.

• Days 1 - 16: Take one red tablet every day for 16 days.
• Days 17 - 28: Take one white tablet every day for 12 days.

Take the tablets with a glass of water. Once you have finished the pack, start a new pack continuing the treatment without interruption. A menstruation-like bleeding (period) usually occurs at the beginning of a new pack. For more information on how to use Novofem®, please see the package leaflet.

Do not take Novofem® if:

• You have, have had or suspect having breast cancer.
• You have, have had or suspect having cancer of the womb lining (endometrial cancer), or any other oestrogen-dependent cancer.
• You have any unexplained vaginal bleeding.
• You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• You have or have ever had a blood clot in a vein (venous thromboembolism), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• You have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• If you have or previously have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• You have or have ever had a liver disease and your liver function tests have not returned to normal.
• If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Novofem®.
• You have a rare blood problem called ‘porphyria’ which is passed down in families (inherited).

If any of the above conditions appear for the first time while taking Novofem®, stop taking it at once and consult your doctor immediately.

There are more warnings associated with the use of Novofem®. All risks and precautions are listed in the package leaflet. Consult a doctor if you are unsure if Novofem® is suitable for you.

Other medicines and Novofem®

Some medicines may interfere with the effect of Novofem®. This might lead to irregular bleeding. This applies to the following medicines:

• Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine).
• Medicines for tuberculosis (such as rifampicin and rifabutin).
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir).
• Medicines for hepatitis C infections (such as telaprevir).
• Herbal remedies containing St John’s Wort (Hypericum perforatum).

Other medicines may increase the effects of Novofem®:

• Medicines containing ketoconazole (a fungicide).

Novofem® may have an impact on a concomitant treatment with cyclosporine.

Note:

• Novofem® can be taken with or without food.
• Novofem® is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.

Novofem® is available on prescription only. The doctor will determine if you are a candidate for this medicine and can write a prescription for Novofem® after an online consultation.

Would you like to know what Novofem® tablets cost? The current price of Novofem® is listed on our order page. The price includes the cost of the consultation and a service fee.

Like all medicines, this medicine can have side effects, although not everybody gets them. The following diseases are reported more often in women using HRT compared to women not using HRT:

• Breast cancer.
• Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer).
• Ovarian cancer.
• Blood clots in the veins of the legs or lungs (venous thromboembolism).
• Heart disease.
• Stroke.
• Probable memory loss if HRT is started over the age of 65.

For more information about these side effects, see the package leaflet.

Hypersensitivity/allergy (uncommon side effect – affects 1 to 10 users in 1,000):

Though it is an uncommon event, hypersensitivity/allergy may occur. Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing, low blood pressure (paleness and coldness of skin, rapid heartbeat), feeling dizzy, sweating, which could be signs of anaphylactic reaction/shock. If one of the mentioned symptoms appears, stop taking Novofem® and seek immediate medical help.

Very common side effects (may affect more than 1 in 10 people):

• Headache.
• Breast tenderness.

Common side effects (may affect up to 1 in 10 people):

• Increased blood pressure, aggravated hypertension.
• Vaginal infection with a fungus (e.g., thrush).
• Dizziness, sleeplessness, depression.
• Dyspepsia (indigestion), abdominal pain, flatulence.
• Nausea (feeling sick).
• Rash, itching.
• Vaginal bleeding (see package leaflet for more information).
• Aggravation of uterine fibroids (benign tumour of the womb).
• Oedema (swelling of hands, ankles and feet).
• Weight increase.

Uncommon side effects (may affect up to 1 in 100 people):

• Migraine.
• Changes in libido (changes in sexual desire).
• Peripheral embolism and thrombosis (blood clot).
• Vomiting (being sick).
• Gall bladder disease or gallstones.
• Hair loss (alopecia).
• Muscle cramps.

What Novofem® contains

The active substances are estradiol and norethisterone acetate.

• The red film-coated tablets contain: estradiol 1 mg (as estradiol hemihydrate).
• The white film-coated tablets contain: estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg.

The other ingredients are: lactose monohydrate, maize starch, hydroxypropylcellulose, talc and magnesium stearate.

Film-coating (red tablets) contains: hypromellose, talc, titanium dioxide (E171), propylene glycol and red iron oxide (E172).